IGD RCT: CBT Treatment of Internet Gaming Disorder

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05328596
Collaborator
(none)
100
2
36

Study Details

Study Description

Brief Summary

For most people, gaming is perceived as a positive activity. In some cases, however, gaming may turn into an addiction with consequences for the individual health, quality of life and everyday life. Today, there is a lack of evidence-based interventions to treat this condition, called Internet Gaming Disorder (IGD). This study will evaluate a new manual for treatment of IGD, divided into a number of modules and based on cognitive behavioural treatment (CBT). The study is designed as a randomized controlled trial (RCT) and will be conducted at a clinic specialized in the treatment of gambling and gaming addiction.

Participants included in the study will be randomized to one of to groups. The intervention group will receive ten weeks of individual CBT-treatment while participants allocated to the control group will be offered a number of short weekly interactive psycho educative sessions.

The hypothesis is that the manual based CBT treatment will result in a greater reduction in number of hours spent on gaming and number of criteria for IGD.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CBT treatment
  • Behavioral: Wait list control
N/A

Detailed Description

The study is designed as a two-armed randomized controlled trial. After inclusion, every participant will be offered social mapping (overview of the participant´s social circumstances) and a review of the participant´s general health (e.g., other addictions, physical activity and dietary habits). Thereafter, the participants will be randomized to one of the two arms.

The main arm includes individual CBT treatment following a new, module-based manual. The manual includes ten weekly sessions addressing different dimensions of gaming disorder, for example thoughts, emotions, and procrastination. Between every session the participants have home assignments to work with, in order to strengthen helpful behaviours. The participants also report amount of time spent on gaming and other activities every week.

Participants randomized to the control arm also report their time spent on gaming and other activities every week. In connection to the registration of gaming time, they also receive short, interactive psycho educative messengers. The control treatment has the same duration as the main arm. Participants in this group will then be offered the same treatment as participants in the main arm.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Internet Gaming Disorder- a Randomized Controlled Trial in a Clinical Setting
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: CBT treatment

The CBT-treatment arm includes a review of the patient´s social conditions and overall health. It also includes manual based Cognitive Behavioural Treatment (CBT) in 10 individual sessions.

Behavioral: CBT treatment
CBT-treatment

Active Comparator: Wait list control

The control treatment includes a review of the patient´s social conditions, overall health and psychoeducation.

Behavioral: Wait list control
No intervention

Outcome Measures

Primary Outcome Measures

  1. IGDS-SF9 [At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)]

    Change in diagnostic criteria of Internet Gaming Disorder

  2. Timeline follow back for gaming [Once a week during the treatment period (week 0-10)]

    Change in time spent on gaming and other activities during the ten week of treatment

Secondary Outcome Measures

  1. Patient health´s questionnaire (PHQ-9) [At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)]

    Change in symptoms of depression

  2. Generalized Anxiety Disorder (GAD-7) [At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)]

    Change in symptoms of anxiety

Other Outcome Measures

  1. Brunnsviken Brief Quality of life scale (BBQ) [At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)]

    Change in questionnaire for quality of life

  2. Gaming Addiction Identification Test (GAIT) [At baseline (Timepoint (T)0), 4 weeks (T1), 5 weeks into treatment (T2), after 10 weeks of treatment (T3), at follow up 3, 6, 12, 18 and 24 months after the end of treatment (T 4-8)]

    Change in presence of Internet Gaming Addiction

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Fulfilling 5 out of 9 criteria for IGD according to DSM V

  • ≥ 16 years of age

  • Can read and speak Swedish fluidly.

Exclusion Criteria:
  • Somatic or psychiatric disease that is contraindicating or severely complicates the implementation of the intervention (e.g., ongoing psychotic, manic or hypomanic episode or neuropsychiatric condition with severe disability)

  • Ongoing increased suicide risk that is considered to make it inappropriate for the patient to participate in the study (based on evaluation at the structured clinical interview)

  • have another ongoing psychological treatment with a content similar to that in the current study

  • plan to start such treatment during the XX weeks that the study is ongoing or has during the last three weeks started or changed medication for any psychiatric problem.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Anna Gordh, Ass. Prof, Mottagning för spelberoende och skärmhälsa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anna Gordh, Associated Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT05328596
Other Study ID Numbers:
  • MSS 2022-IGD RCT
First Posted:
Apr 14, 2022
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anna Gordh, Associated Professor, Sahlgrenska University Hospital, Sweden
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022